Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03841175
Other study ID # RENOVATE ( 29BRC18.0012)
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2018
Est. completion date August 1, 2018

Study information

Verified date April 2018
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Head and neck (HN) cancer is the sixth most common malignancy worldwide, with around 800 000 new cases and 320 000 deaths in 2015. These malignancies encompass cancers of the oral cavity, oropharynx, hypopharynx and larynx and concern squamous cell carcinomas (HNSCC) 90% of the time. Despite aggressive treatment strategies, the five-year survival rate has only marginally improved in the past decade. The prognosis is strongly dependent on initial staging. The 5-year relative survival rate is 80,3% for patients with localized disease whereas it decreases to 47.2% when regional lymph node metastasis is known, and to 32.5% when distant metastasis is known. Hence, precise cancer staging is essential as it allows clinicians to select the appropriate treatment strategies and predict the prognosis of the patients.

The conventional work-up (CWU) includes physical examination, endoscopy, computed tomography (CT) and/or magnetic resonance imaging (MRI) of the head and neck to evaluate the initial local and regional HNSCC staging. Thoracic CT is recommended because the thorax is the most frequent location of remote metastasis and synchronous second cancer outside of the upper aerodigestive tract.

Some authors demonstrated that 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET) had a higher sensitivity and specificity for determining the extent of the disease and was able to detect occult second primaries. Moreover 18-FDG PET-CT allows whole body assessment. This is why the use of 18-FDG PET-CT has increased significantly over the last several years. Added to initial CWU, 18-FDG PET-CT may restage HNSCC and as a result may alter the clinical management.

Pre-therapeutic 18F-FDG PET/CT is recommended by guidelines to assess remote extension of locally advanced HNSCC and/or to look for synchronous cancer but is not systematically indicated, particularly for localized disease.

Restaging impact on prognosis and clinical management remains poorly understood.

Therefore, the objective of this study is to assess the impact of the additional information provided by 18F-FDG PET-CT on HNSCC initial staging and whether restaging modify prognosis and clinical management, whatever the CWU stage.


Recruitment information / eligibility

Status Completed
Enrollment 477
Est. completion date August 1, 2018
Est. primary completion date August 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- biopsy proven HSNCC

- written consent

Exclusion Criteria:

- previous head and neck malignancy

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHRU de Brest Brest

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prognostic impact of initial restaging HNSCC with 18F-FDG PET-CT Overall survival 10 years
See also
  Status Clinical Trial Phase
Withdrawn NCT05331131 - Efficacy of Ketamine Mouthwash in the Management of Oral and Pharyngeal Toxicity Associated With Head and Neck Chemoradiotherapy: A Phase 2, Simon 2-stage Trial Phase 2
Completed NCT05269342 - Nurse-led Exercise Improves Shoulder Pain, Shoulder Disability, and Quality of Life in Head and Neck Cancer N/A
Completed NCT03574870 - Wearable Sensor for Biometrics During Locoregional Therapy for Head and Neck Cancer N/A
Recruiting NCT04804852 - Assessment of the Prevalence of Sarcopenia by CT Scan in Patients Diagnosed With Head & Neck Cancer
Active, not recruiting NCT04617678 - A Comprehensive Approach to Head and Neck Cancer Prehabilitation N/A
Completed NCT03419741 - Brain Stimulation For Cancer Smokers N/A
Recruiting NCT02528955 - De-Intensification Radiotherapy Postoperative Head Neck Phase 2
Completed NCT00318890 - Cisplatin and Docetaxel Plus Docetaxel and Radiotherapy With Amifostine for Squamous Cell Carcinoma of the Head and Neck Phase 1/Phase 2
Recruiting NCT05179824 - Tempus Priority Study: A Pan-tumor Observational Study
Recruiting NCT05316974 - Lymphoedema Among Persons With Head- and Neck Cancer
Not yet recruiting NCT03954691 - Targeting Potassium Channels to Reprogram Glioblastoma Microenvironment: in Vitro and in Vivo Studies
Active, not recruiting NCT03760471 - Palliative and Oncology Care Intervention: Symptom COACH N/A
Completed NCT04554667 - Heavy Lifting Strength Training in Head and Neck Cancer Survivors Phase 1
Completed NCT02869399 - Tertiary Prevention of Head and Neck Cancer With a Dietary Intervention N/A
Completed NCT02366611 - Pain Control Using Neuromodulation in Patients Undergoing Definitive Chemoradiotherapy for Head and Neck Cancer N/A
Completed NCT02075112 - Soy Isoflavone in Combination With Radiation Therapy and Cisplatin in SCC of the Head and Neck Phase 1
Completed NCT00798655 - Trial of Postoperative Radiation, Cisplatin, and Panitumumab in Locally Advanced Head and Neck Cancer Phase 2
Completed NCT02900911 - Swallowing Rehabilitation in Patients With Head and Neck Cancer Receiving Radiotherapy N/A
Completed NCT01317589 - Treatment of Pain in Head-and-Neck Cancer Patients: is Methadone More Effective? Phase 4
Completed NCT02865135 - Trial To Test Safety And Efficacy Of Vaccination For Incurable HPV 16-Related Oropharyngeal, Cervical And Anal Cancer Phase 1/Phase 2